Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Lack of processing controls
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Low out of specification results for epinephrine assay.
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Failed Impurities/Degradation Specifications
Label declares lecithin but does not declare soy lecithin.
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
FDA inspection found New Dietary Ingredient, Hordenine, in the supplement product.
cGMP deviations: Discolored acetaminophen
CGMP Deviations
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.